Kornimate/medical-research-clean huggingface dataset:
compare vaginal estrogen and platelet-rich plasma over women with genitourinary syndrome of menopause

Conditions: Menopause; Platelet-rich Plasma; Estrogen Replacement Therapy; Vaginal Atrophy

Summary: the definition of genitourinary syndrome of menopause (gsm) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia. the treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (mi), vaginal ph, and other methods will be used for evaluation of the effectiveness and side effects.


Eligibility criteria:
inclusion criteria: * women with menopause * patients with symptoms of genitourinary syndrome of menopause exclusion criteria: * genitourinary bleeding or infection without definitive diagnosis * coagulopathy * allergy to medication or therapy related with the treatment * chronic disease that might influence outcome * using medication that might influence outcome in 30 days * using hormone or steroid within 8 weeks
effects of vivatlac baby on crying behavior of colicky babies

Conditions: Infantile Colic

Summary: open trial with two parallel arms, assessing the effects of simethicone and vivatlac baby in babies diagnosed for infantile colic.

babies aged 3 to 6 weeks will be diagnosed for infantile colic using the wessel's criteria. study design will be open label with two parallel arms (simethicone and vivatlac baby). vivatlac baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.

Eligibility criteria:
inclusion criteria: * diagnosed for infantile colic according to wessel's criteria exclusion criteria: * previous treatment with probiotic or synbiotic * previous treatment with antibiotics
anterior vertebral body tethering (avbt) using zimmer biomet tether system or dynesys system components to treat pediatric scoliosis

Conditions: Scoliosis

Summary: the researchers want to assess the short-term safety of anterior vertebral body tethering (avbt) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.


Eligibility criteria:
inclusion criteria: 1. male \& female, age 10 years to 16 years. 2. scoliosis curve between 40-70 degrees. 3. at least 1 year of growth remaining measured by sanders bone age 4 or less or risser stage 2 or less. 4. adolescent idiopathic scoliosis. 5. lenke 1, 2, 3c, 5 (thoracic, thoracolumbar, or thoracic and lumbar). 6. parents must be able to understand the study and sign the consent document. assent will be obtained and documented as age appropriate. 7. patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits. exclusion criteria: 1. congenital, neuromuscular or syndromic scoliosis. 2. underlying neuromuscular disease. 3. pregnancy. 4. nonflexible curves (bending films show residual curve greater than 40 degrees). 5. prior surgery for scoliosis treatment. 6. patients with active systemic infection. 7. known, reported allergies to titanium, pet, or pcu. known, reported substance abuse, including alcohol.
evaluation of apnealink plus scoring capabilities

Conditions: Sleep Apnea, Central; Sleep Apnea, Obstructive

Summary: the purpose of this study is to investigate the following topics: * determine the accuracy of apnealink plus in separating apneas into obstructive apneas, mixed apneas and central apneas. * determine the accuracy of apnealink plus in scoring hypopneas according to the 2008 guidelines of the aasm = american academy of sleep medcine. * determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet

* determine the accuracy of apnealink plus in separating apneas into obstructive apneas, mixed apneas and central apneas. * determine the accuracy of apnealink plus in scoring hypopneas according to the 2008 guidelines of the aasm = american academy of sleep medcine. * determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet

Eligibility criteria:
inclusion criteria: * willing to give written informed consent * adult patients who are 18 years of age or older * no alcohol consumption 12 hrs before and during the trial period * normally sleep more than 3 hours per night exclusion criteria: * unable to comprehend written and spoken german. * pregnant * patients who use of bilevel pap or cpap therapy during the psg * unsuitable for inclusion in the opinion of the investigator
rgd-k5 in head and neck cancer patients

Conditions: Head and Neck Neoplasms

Summary: 1. primary endpoint(s): to determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients. 2. secondary endpoint(s): to expand the safety database of \[f-18\]rgd-k5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

this is an uncontrolled, open-labeled, non-randomized, prospective study. the study duration is expected to be completed in a period of 3 year. up to 100 patients would be included. group a would be those to undergo surgical excision or biopsy (n=20); group b would be those with n2c-3m0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and group c would be those with m1 disease to receive biotherapy or chemotherapy (n=40). group a patients could be included into group b or c if qualified. each participant must fulfill all the inclusion and exclusion criteria.

Eligibility criteria:
inclusion criteria: * head and neck cancer patients (including nasopharyngeal cancer) * age equals or more than 20 years old * referred by chang gung memorial hospital (cgmh) head and neck oncology team. * willing to sign the informed consent exclusion criteria: * patient who is pregnant or lactating; * patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy; * unable to tolerate mr or pet/ct scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still. * unable to give informed consent
alberta diabetes and physical activity trial

Conditions: Type 2 Diabetes

Summary: this project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with type 2 diabetes.

an increasing prevalence of type 2 diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. in canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be type 2. strong evidence supports the importance of physical activity in the management of type 2 diabetes. however, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. the call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management type 2 diabetes remains largely unheeded. the three interventions are: (1) standard print-based physical activity educational materials provided by the canadian diabetes association (cda); (2) cda materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.

Eligibility criteria:
inclusion criteria: \>18 years old, type 2 diabetes, living in the province of alberta, can communicate in english. exclusion criteria: serious contraindications to physical activity

Keywords: diabetes physical activity
study to assess the efficacy and safety of a parp inhibitor for the treatment of brca-positive advanced breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of the study is to see if the drug ku-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (brca)1- or brca2-positive advanced breast cancer and for whom no curative therapeutic option exists.

this is a phase ii, open-label, non-comparative, international, multicenter study to assess the efficacy and safety of olaparib when given orally twice daily (bd) in participants with advanced brca1- or brca2- associated breast cancer. two sequential participant cohorts will receive continuous oral olaparib in 28-day cycles. the first cohort will receive 400 mg bd and the second cohort will receive 100 mg bd.

Eligibility criteria:
inclusion criteria: * advanced breast cancer with positive brca1 or brca2 status * failed at least one prior chemotherapy * in investigators opinion, no curative standard therapy exists * measurable disease exclusion criteria: * brain metastases * less than 28 days since last treatment used to treat the disease * considered a poor medical risk due to a serious uncontrolled disorder

Keywords: advanced breast cancer poly(adp ribose) polymerases azd2281,ku-0059436 (olaparib) brca1 protein brca2 protein
angiotensin ii stress test. renin kinetics during treatment of vasoplegic shock with angiotensin ii.

Conditions: Shock; Vasoplegic Syndrome

Summary: shock is a life-threatening condition which can cause multiple organ failure and even death. one characteristic of shock is low blood pressure which is managed with drugs called vasopressors. most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin ii. angiotensin ii is present in the body and has a physiological role in maintaining blood pressure in healthy persons. renin is an enzyme and a key factor in angiotensin ii production in the body. in patients with shock, there is a lack of angiotensin ii and an excess of renin in the body. due to the literature renin has the potential to be a marker of severity of shock. synthetic angiotensin ii is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. regarding scientific data, the use of synthetic angiotensin ii reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. the aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin ii in patients with shock and their clinical outcome. since not all patients with shock are responding to angiotensin ii, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin ii.

in patients with distributive shock (≥18 years) with noradrenaline \>0,3 mcg/kg/min and vasopressin \>0,03 ie/min not achieving an appropriate mean arterial pressure (65-85 mmhg) an angiotensin ii infusion will be started at 20 ng/kg/min and after that adjusted to a max dose of 40 ng/kg/min if needed. before the infusion and 6 hours after the start of angiotensin ii infusion a blood sample will be drawn to determine the renin concentration. the primary outcome will be organ failure free days and icu free days. secondary outcome will be the need for vasopressors, dialysis, mechanical ventilation, trend of renin concentration.

Eligibility criteria:
inclusion criteria: * patients with distributive shock lasting \< 72 hours * a goal mean arterial pressure (65-85 mmhg) not achieved despite an infusion of at least noradrenaline 0.3 mcg/kg/min and vasopressin 0.03 ie/min * the patient did not get angiotensin ii before * predicted survival is \>24h * no limitations for active treatment exclusion criteria: * burns \>20% body area * acute coronary syndrome * bronchospasm * liver disease (meld ≥30) * severe acute bleeding (need for 4 or more units of concentrated erythrocyte) * acute mesenteric ischemia * aortic dissection * leucopenia \<1000/mm3 * pregnancy * raynaud disease, systemic sclerosis, vasospastic disease * the need for daily dose of hydrocortisone 500 mg or more * ecmo

Keywords: shock, distributive angiotensin ii renin shock, septic vasoplegia
a prospective clinical study for evaluation of safe resection margin in breast conserving surgery in breast cancer

Conditions: Breast Cancer

Summary: near-infrared (nir) fluorescence imaging using indocyanine green (icg) has been used for breast cancer surgery such as sentinel lymph node (sln) mapping and breast cancer localization. in this study, our hypothesis are as following: 1. as inject only indocyanine green (icg), it provide the surgeon visual guidance to ensure better outcome. 2. indocyanine green (icg) permitted accurate preoperative and intraoperative detection of the slns as well as nonpalpable benign brest lesion in patients with breast cancer.

indocyanine green, icg (icg-fluorescence) * icg is the most commonly used fluorophore which approve by fda. * nir-f imaging with icg could be used in various surgeries. for example, sln mapping in breast cancer and localization of liver metastasis, especially superficial lesion * contains sodium iodide, patients who have history of allergy to iodides should be used as caution. nonpalpable benign brest lesion localization * new method for the localization and resection of non-palpable breast lesions. * the breast lesion was correctly localized, and the area of icg corresponded well to the site of the lesions.

Eligibility criteria:
inclusion criteria: * nonpalpable breast tumor \< 5cm in patients with breast cancer. * consented patients with more than 18 years * eastern cooperative oncology group performance status 0 or 1 * patients who need breast biopsy as treatment for breast cancer. exclusion criteria: * nonpalpable breast tumor ≥ 5cm in patients with breast cancer. * inflammatory cancer of breast or patients who need mrm * pregnancy * history of severe allergy to icg(indocyanine green) * iode hypersensitiveness

Keywords: near-infrared fluorescence indocyanine green, icg breast cancer
is a carnitine based food supplement (porimoretm) for infertile men superior to folate and zinc with regard to pregnancy rates in intrauterine insemination cycles?

Conditions: Male Infertility

Summary: many cases of male infertility are poorly understood and regarded as unexplained. therefore, a etiological treatment for this condition can not be offered in most cases. a beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. however, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. in this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (porimore) or folate and zinc tablets.


Eligibility criteria:
inclusion criteria: * infertility * at least one abnormal sperm quality parameter * female age \< 35 * normal ovarian reserve exclusion criteria: * known allergy to one of the food additives planned for treatment

Keywords: sperm male infertility carnitine food supplementation insemination
thoracentesis: symptoms and prediction of the need for therapeutic thoracentesis

Conditions: Pleural Effusion; Dyspnea; Patient Reported Outcomes; Diaphragm Movement; Ultrasound

Summary: recurrent fluid surrounding the lungs is associated with poor quality of life, the main symptom being dyspnea. these patients are in need of recurrent removal of the fluid using drainage. the mechanism causing dyspnea is not fully understood. by using ultrasound to evaluate the movement of the diaphragm before and after removal of fluid and the patients symptoms before removal of fluid and until next removal the research group aims to clarify the temporal development in symptoms and the role of the diaphragm. the researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next removal of fluid in patients with recurrent unilateral pleural effusion.

recurrent pleural effusion (pe) is associated with impaired quality of life, the main symptom being dyspnea. the mechanisms causing dyspnea in pe is not fully understood. these patients are in need of recurrent therapeutic thoracentesis. by evaluating the movement of diaphragma before and after thoracentesis and measure the patients symptoms before thoracentesis and until the next thoracentesis the researchers aim to clarify the temporal development in symptoms and the role of the diaphragm. the researchers will also evaluate the ability of the pulmonologist and patient to predict when the patient will need the next therapeutic thoracentesis in patients with recurrent unilateral pleural effusion.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * unilateral pleural effusion. * a minimum of two thoracentesis prior to inclusion. * patients must be able to give informed consent. exclusion criteria: * bilateral pleural effusions. * inability to understand written or spoken danish.
logistic regression of risk factor for the 5-year mortality of aortic dissection

Conditions: Aortic Dissection

Summary: the relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. the aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from aug. 2001 to aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.

clinical data were collected from 111 hospitalized patients admitted to hospital from aug. 2001 to aug.2007, and the related factors for death within 5 years after the onset of dissection, which include gender, age, history of smoking, hypertension, diabetes, renal insufficiency (azotemia), low admission diastolic blood pressure (\<70mmhg), stanford typing (stanford a or b), long-acting calcium channel blocker treatment,acei /arb treatment, endovascular stent and surgical aortic replacement,were statistically analyzed by univariate and multivariate binary logistic regression.

Eligibility criteria:
inclusion criteria: * stanford type a dissection * stanford type b dissection exclusion criteria:
comparison between bilateral infraorbital block versus intranasal bupivacaine in transsphenoidal pituitary adenoma resection

Conditions: Intraoperative Hypertension

Summary: the study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.


Eligibility criteria:
inclusion criteria: * asa i, ii or iii * patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia exclusion criteria: * patient's refusal * allergy to local anesthetics. * preoperative cerebrospinal fluid leak. * preoperative cardiac arrythmias. * seizure disorders. * patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.
electrical stimulation for the treatment of pain following total knee arthroplasty (tka) using the sprint system

Conditions: Total Knee Replacement; Total Knee Arthroplasty; Pain; Postoperative Pain; Orthopedic Disorders

Summary: the purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (tka)). this study involves a device called the sprint system. the sprint system delivers mild electrical stimulation to nerves in the leg that received the knee replacement. the sprint system includes a small wire (called a "lead") that is placed through the skin in the upper leg. it also includes a device worn on the body that delivers stimulation (called the sprint stimulator).


Eligibility criteria:
key inclusion criteria: * at least 21 years old * scheduled to undergo a primary unilateral total knee replacement procedure key exclusion criteria: * body mass index (bmi) \> 40 kg/m2 * compromised immune system based on medical history * history of valvular heart disease * implanted electronic device * joint or overlying skin infection of the affected limb * history of recurrent skin infections * bleeding disorder * allergy to skin surface electrodes and/or medical-grade adhesive tapes * pregnant

Keywords: electrical stimulation neurostimulation neuromodulation tka pain pain following total knee replacement total knee arthroplasty